Non-sterile convenience kits: Medline Open Heart CDS — Class II medical device recall Z-2231-2024
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-07-10, distributed nationwide. Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in
| Recall number | Z-2231-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-03-14 |
| Classified | 2024-06-28 |
| Reported by FDA | 2024-07-10 |
| Distributed | Nationwide (US) |
| Quantity | 7,673 non |
| Reason classes | sterility, packaging |
| Lot numbers | 23EDA124, 23IDA683, 23JDA205, 23KDB724, 24ADA460 |
| Expiration dates | 2025-05-31, 2025-07-31, 2025-10-31, 2025-11-30 |
Product
Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile.
Reason for recall
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2231-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.